{"id":30149,"date":"2026-02-13T15:40:38","date_gmt":"2026-02-13T15:40:38","guid":{"rendered":"https:\/\/www.bpa-solutions.net\/?page_id=30149"},"modified":"2026-02-17T13:44:37","modified_gmt":"2026-02-17T13:44:37","slug":"compliance-with-iso13485","status":"publish","type":"page","link":"https:\/\/www.bpa-solutions.net\/fr\/compliance-with-bpa\/compliance-with-iso13485\/","title":{"rendered":"Compliance with ISO13485"},"content":{"rendered":"

[et_pb_section fb_built=”1″ custom_padding_last_edited=”on|phone” admin_label=”Title” module_id=”partner-program” module_class=”software-banner” _builder_version=”4.27.4″ _module_preset=”default” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ width=”90%” max_width=”1600px” module_alignment=”center” custom_margin=”0px||||false|false” custom_padding=”150px|0px|75px|0px|false|false” custom_padding_tablet=”150px|0px|25px|0px|false|false” custom_padding_phone=”||0px||false|false” hover_transition_duration=”0ms” background_image_tablet=”https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2023\/07\/Document-Control-Software-tablet.png” background_enable_image_tablet=”on” background_enable_image_phone=”off” custom_css_free_form=”selector p{color:#343434 !important}” locked=”off” global_colors_info=”{}” custom_css_before__hover_enabled=”on|desktop”][et_pb_row column_structure=”1_2,1_2″ use_custom_gutter=”on” gutter_width=”4″ make_equal=”on” module_id=”hero-row-text-img” _builder_version=”4.25.2″ _module_preset=”default” module_alignment=”center” custom_margin=”||15px||false|false” custom_padding=”|0px||0px|false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.25.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_code disabled_on=”off|off|off” admin_label=”breadcrumbs” module_class=”breadcrumbs” _builder_version=”4.25.2″ _module_preset=”default” vertical_offset_tablet=”0″ horizontal_offset_tablet=”0″ z_index_tablet=”0″ box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” global_module=”19802″ saved_tabs=”all” global_colors_info=”{}”]Home<\/a><\/span><\/span>[\/et_pb_code][et_pb_heading title=”ISO\/IEC 13485 made practical” _builder_version=”4.25.2″ _module_preset=”default” max_width=”80%” global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.5″ _module_preset=”default” text_font_size=”16px” text_line_height=”1.3em” custom_margin=”50px||50px||false|false” locked=”off” global_colors_info=”{}”]<\/p>\n

ISO 13485:2016 is the international benchmark for quality management systems in the medical device industry, defining strict requirements to ensure product safety, regulatory compliance, and full traceability across the product life cycle. As global regulations increasingly align with ISO 13485, organizations must implement structured, risk based, and audit ready processes that go beyond documentation and enable effective operational compliance.<\/p>\n

Our ISO 13485 standard to feature mapping guide shows how BPAMedical365, directly supports each clause through integrated document control, CAPA, supplier management, traceability, and automated workflows.<\/p>\n

Download the guidebook to explore the detailed clause by clause mapping and learn how BPA enables efficient, secure, and scalable ISO 13485 compliance.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”#Guidebook-form” button_text=”Download guidebook” module_class=”primary-cta” _builder_version=”4.27.5″ _module_preset=”default” custom_button=”on” button_text_size=”16px” button_bg_color=”#9dc73b” button_border_width=”0px” button_border_radius=”4px” button_icon=”||fa||900″ button_on_hover=”off” background_layout=”dark” custom_margin=”10px||40px||false|false” custom_padding_tablet=”” custom_padding_phone=”10px|45px|10px|25px|false|false” custom_padding_last_edited=”on|phone” locked=”off” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.25.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2026\/01\/Screenshot-2026-01-19-093025.png” alt=”ISO\/IEC 27001 made practical” title_text=”ISO\/IEC 27001 made practical” _builder_version=”4.27.5″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Advanced Features Grid” module_id=”features-block” module_class=”section-features-block” _builder_version=”4.27.5″ _module_preset=”default” width=”90%” max_width=”1600px” module_alignment=”center” custom_margin=”55px||10px||false|false” custom_margin_tablet=”25px||25px||false|false” custom_margin_phone=”||0px||false|false” custom_margin_last_edited=”on|desktop” custom_padding=”|0px||0px|false|false” custom_css_free_form=”selector .list-item{|| display:flex !important;|| flex-direction:column;|| column-gap: 10px !important;|| pointer-events:none !important;||}||selector .list-item:hover{|| background:transparent !important;|| height:20px !important;||}||||#features-block li{|| font-size:14px;|| line-height: 2||}||#features-block ul {|| list-style-image: url(‘https:\/\/www.bpa-solutions.net\/wp-content\/uploads\/2024\/04\/checkbox.svg’);|| list-style-position: outside;|| padding-left:25px;||}” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_3,1_3,1_3″ make_equal=”on” disabled_on=”off|off|off” admin_label=”Grid” _builder_version=”4.27.5″ _module_preset=”default” custom_padding=”|0px||0px|false|false” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.27.5″ _module_preset=”default” background_color=”#40690d” use_background_color_gradient=”on” background_color_gradient_direction=”293deg” background_color_gradient_stops=”#93bc22 0%|#425b10 100%” custom_padding=”30px|30px|30px|30px|true|true” custom_css_main_element=”display:flex;||flex-direction:column;||justify-content: flex-start;||align-items: flex-start;||column-gap: 25px;” border_width_all=”1px” border_color_all=”#d9d9d9″ global_colors_info=”{}”][et_pb_heading title=”Clause 4″ _builder_version=”4.27.0″ _module_preset=”default” title_level=”h3″ title_text_color=”#FFFFFF” custom_margin=”||20px||false|false” global_colors_info=”{}”][\/et_pb_heading][et_pb_heading title=”GENERAL REQUIREMENTS” _builder_version=”4.27.5″ _module_preset=”default” title_level=”h5″ title_text_color=”#FFFFFF” custom_margin=”||||false|false” global_colors_info=”{}”][\/et_pb_heading][et_pb_heading _builder_version=”4.27.5″ _module_preset=”default” title_level=”h6″ title_text_color=”#FFFFFF” custom_margin=”||||false|false” global_colors_info=”{}”][\/et_pb_heading][et_pb_text module_class=”form-text” _builder_version=”4.27.5″ _module_preset=”default” text_text_color=”#FFFFFF” text_font_size=”16px” text_line_height=”1.3em” header_text_align=”left” header_text_color=”#FFFFFF” header_6_text_color=”#FFFFFF” locked=”off” global_colors_info=”{}”]<\/p>\n

Establish and maintain a compliant QMS, including a controlled Quality Manual defining scope and processes. Define and assign roles and responsibilities to ensure accountability and traceability. Maintain Medical Device Files with complete design, specification, and manufacturing documentation. Control documents with approval workflows, version control, and revision tracking. Manage document and record lifecycle, ensuring secure storage, traceability and proper disposal.<\/p>\n

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How BPA eQMS helps<\/span><\/strong><\/h6>\n

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